Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR)

University of California San Francisco (UCSF)

Status and phase: Terminated; Phase 4

Conditions: Implementation; Child Health; Morality; Resistance Bacterial

Treatments: Drug: Azithromycin for Oral Suspension

Study type: Interventional

Funder types: Other

Identifiers

NCT05288023

19-28387C

Details and patient eligibility

About

The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings. The proposed trial aims to demonstrate and evaluate large-scale implementation of azithromycin to children aged 1-11 months old in the context of a programmatic setting while monitoring mortality and resistance antimicrobial resistance.

Full description

In the Programmatic Trial, community health centers (also known as "CSIs" or "Centres de Santé Intégrés") will be randomized to one of two arms: 1) programmatic azithro 1-11: biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers or 2) no intervention: no distribution of azithromycin. A total of 2,490 communities within selected CSIs will be included .

All communities in both arms receive routine health services offered by community health workers working for the Niger Ministry of Health's community health program.

Mortality will be monitored through birth histories. Mortality and morbidity will also be monitored using routinely collected community and clinic visit data. Antimicrobial resistance will be monitored in a subset of eligible CSIs.

Enrollment: 169,707 patients

Sex: All

Ages: 1+ month old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Intervention

At the community-level, eligibility includes:

Inclusion Criteria:

• Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions
• Distinguishable from neighboring communities
• Verbal consent of community leader(s)

Exclusion criteria:

• Inaccessible or unsafe for study team
• "Quartier" designation on national census

At the individual-level, eligibility includes:

Inclusion criteria:

• Age 1-11 months
• Primary residence in a study community
• Verbal consent of caregiver/guardian for study participation

Exclusion criteria:

• Known allergy to macrolides

Population-based sample collections

At the community-level, eligibility includes:

Inclusion criteria:

• Location in study region
• Distinguishable from neighboring communities
• Verbal consent of community leader(s)

Exclusion criteria:

• Inaccessible or unsafe for study team
• Included in MORDOR trials
• Not randomly selected

At the individual-level, eligibility includes:

Inclusion criteria:

• Age 1-59 months or 7-12 years or caregiver/guardian of a child eligible for treatment
• Primary residence in a study community selected for sample collections
• Verbal consent of caregiver/guardian for study participation

Exclusion criteria:

• Not on list of randomly selected participants from the census

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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169,707 participants in 2 patient groups

Programmatic azithro 1-11

Active Comparator group

Description:

Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers

Treatment:

Drug: Azithromycin for Oral Suspension

no intervention

No Intervention group

Description:

No additional intervention.